2014年9月29日 星期一

A drug used to treat advanced breast cancer has had what appears to be unprecedented success in prolonging lives in a clinical trial, researchers reported on Sunday.

Patients who received the drug — Perjeta, from the Swiss drug maker Roche — had a median survival time nearly 16 months longer than those in the control group.

That is the longest amount of time for a drug used as an initial treatment for metastatic breast cancer, the researchers said, and it may be one of the longest for the treatment of any cancer.

Most cancer drugs prolong survival in patients with metastatic disease for a few months at most. Metastasis means the cancer has spread to other parts of the body.

“We’ve never seen anything like this before,” said Dr. Sandra M. Swain of the MedStar Washington Hospital Center in Washington, the lead author of the study. “It’s really unprecedented to have this survival benefit.”

The results were being presented on Sunday in Madrid at the annual meeting of the European Society for Medical Oncology. Dr. Swain has been a paid speaker for the company.

Previous analyses of the clinical trial established that Perjeta, known generically as pertuzumab, increased survival by a statistically significant amount. But until now it was not known by how much, because patients had not been followed long enough.

Two experts not involved in the study, Dr. Edith A. Perez of the Mayo Clinic in Jacksonville, Fla., and Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston, said the results were impressive. “Usually we see two months of improvement,” Dr. Perez said.

Perjeta, like the better-known Roche drug Herceptin, or trastuzumab, blocks the action of a protein called HER2, which spurs the growth of some breast tumors. Perjeta is meant to be used with Herceptin for the roughly 20 percent of breast cancers characterized by an abundance of HER2.

Perjeta was approved by the Food and Drug Administration in 2012 and is already considered the standard of care in the United States.

Still, the results could lead to increased use of the drug. Only about half of the eligible women are being treated with the drug in the United States, according to Edward Lang Jr., a spokesman for Roche. And doctors say use is lower in many countries where cost is more of an issue.

In the United States, Perjeta costs about $5,900 a month and Herceptin about $5,300 a month, Mr. Lang said. He said Perjeta was priced lower than some other new cancer medicines because it has to be used with Herceptin. Some recently approved cancer drugs cost more than $10,000 a month.

Roche reported Perjeta sales of 388 million Swiss francs, or about $408 million, in the first half of this year, with about $250 million of that coming from the United States.

The trial, sponsored by Roche, involved 808 patients around the world with previously untreated HER2-positive metastatic breast cancer. Half of them received Perjeta, Herceptin and the chemotherapy drug docetaxel. The other half received Herceptin, docetaxel and a placebo in place of Perjeta.

The median survival time for those who received Perjeta was 56.5 months, or about four and a half years, compared with 40.8 months for those in the control group, a difference of 15.7 months. By another measure, known as the hazard ratio, use of Perjeta reduced the risk of dying 32 percent.

Use of Perjeta delayed the progression or worsening of the cancer only about six months in the trial. Experts said it was not clear why the drug extended lives so much longer than that.

Those receiving Perjeta had higher rates of diarrhea and rash and a lowering of white blood cell counts.

The labels for both Perjeta and Herceptin contain warnings that the drugs can cause cardiac dysfunction and heart failure. But in the study, patients who received Perjeta did not experience any more of these problems than those in the control group.

Dr. Perez and Dr. Burstein, the experts not involved in the study, said in separate interviews that they were also cheered by a nearly 41-month median survival in the control group.

When Herceptin was approved in the late 1990s, people taking that drug lived a median of about 25 months. The experts said doctors now use Herceptin for a longer time and can better manage patients.

2014年9月28日 星期日

The LRAD is the round black device on top of the New York City police Hummer.

The Long Range Acoustic Device (LRAD), also known as a sound cannon, is an acoustic hailing device and sonic weapon developed by LRAD Corporation to send messages, warnings, and harmful, pain inducing tones over longer distances than normal loudspeakers. LRAD systems have been used to counter piracy, as non-lethal crowd control weapons, and as communication devices.

According to the manufacturer's specifications, the systems weigh from 15 to 320 pounds (6.8 to 145.1 kg) and can emit sound in a 30° beam at 2.5 kHz.[1]

LRAD systems are used by maritime, law enforcement, military and commercial security companies to send instructions and warnings over distances, and to force compliance. LRAD is also used to deter wildlife from airport runways, wind and solar farms, nuclear power facilities, mining and agricultural operations and other industrial facilities.

He says we need a "new normal" when it comes to assuring human safety in cars

A week after facing blistering criticism for his agency’s handling of the recent General Motors (GM) auto recall, the man charged with running the nation’s auto-safety administration acknowledged that his office needs to improve.

“Any life lost is one too many; anything that we can do to improve in a situation like this, we’ve got to do,” David Friedman, interim head of the National Highway Traffic Safety Administration (NHTSA), tells TIME in his first interview since the hearing. “We need a new normal when it comes to recalls.”

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A more combative relationship that keeps “every car company on their toes” is at the heart of Friedman’s “new normal” and carried out through increased financial penalties on car companies and an expanded budget.

“Dropping the ball will not be tolerated,” Friedman said.

In the months since GM announced its first recalls for ignition switch problems, critics have hounded the automaker for taking so long to address an issue that affected millions of cars and killed at least 21 people. More recently, criticism has turned to NHTSA. The agency, created in the 1970s to oversee a powerful industry, is charged with ensuring automakers meet safety standards on everything from brakes to windshields. But its actual authority remains hampered: it can levy a maximum fine of $35 million for a violation and has no power to bring criminal charges.

Friedman wants to change that, and advocates say he should step on it. “This is the best opportunity to reform NHTSA, really, since the original Safety Act was passed in 1966,” says Center for Auto Safety executive director Clarence Ditlow. “When a GM president has to apologize for their safety inaction, that shows you how bad the situation is.”

The reaction centers on faulty ignition switches in millions of GM vehicles that in some cases abruptly shut down the engine and kept airbags from deploying in the subsequent crash. The automaker had been aware of issues with the switch—though perhaps not the extent of the problem—for more than a decade prior to issuing recalls, investigations have shown. NHTSA also received strong evidence of the safety issue in 2007, when Wisconsin officials told the federal agency about what they suspected was a link between ignition switches and airbags. NHTSA officials “either overlooked or failed to understand” the implications of the Wisconsin report and didn’t follow up appropriately, according to a congressional report released last week.

Supporters of reform, both in Congress and among the ranks of safety advocates, say the needed changes are multifaceted: The agency requires expanded enforcement power, increased funding and greater transparency so that the public can hold it accountable.

The agency was granted just over $10 million to investigate defects in 2014, a paltry sum considering the 250 million vehicles on the road in the United States. Overall, the agency devotes about $130 million annually to vehicle safety research—a total that outrages auto-safety advocate Ralph Nader. “It’s about the cost of three months of guarding the US embassy in Baghdad,” Nader tells TIME.

“If Congress would give us another 20 people and $20 million, we could do a lot more for the American public to save lives,” Friedman says.

Increased authority also ranks high on the list of the changes safety advocates say NHTSA needs. Currently, the agency can fine automakers a maximum of $35 million for safety violations, a pittance for an industry that brings in billions each year. Friedman, along with President Obama and transportation secretary Anthony Foxx, wants to raise the cap to $300 million.

But changes to funding or regulatory authority would require Congress to act. A number of legislative proposals have been introduced, but it remains unclear whether this opportunity, as good as it may be, can overcome gridlock.

Friedman says his agency will do its best to improve, even if it doesn’t receive help from Capitol Hill. “If Congress fails to act, we’re a scrappy organization. We punch above our weight,” he says. “We’ll do everything with the resources we can.”

Nader, along with others, says he is skeptical, but ultimately, external pressures may make the question of whether NHTSA officials want to change irrelevant.

“I think the agency will change,” says Joan Claybrook, who ran the agency during Jimmy Carter’s presidency. “If it doesn’t they’re in trouble.”